Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic … (NCT01741857) | Clinical Trial Compass
UnknownPhase 1/2
Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus Erythematosus
China40 participantsStarted 2012-01
Plain-language summary
This study will explore safety and efficacy of allogeneic umbilical cord (UC) derived mesenchymal stem cells transplantation (MSCT) to treat patients with active and refractory systemic lupus erythematosus (SLE) who have been resistant to multiple standard treatments. The underlying hypothesis is that the active SLE condition is caused by an abnormal immune homeostasis that can be restored by MSCT.
Who can participate
Age range
15 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 60 years old, SLEDAI≥8;
* Lupus nephritis with 24h urine protein≥1g;
* Refractory disease as determined by failure of the following regimens:
Trial of corticosteroids (oral prednisone more than 20 mg/day); Trial of cyclophosphamide 0.4 \~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as mycophenolate mofetil 2 g / day, for three months;
* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
* Willing to use contraception throughout the study and for 12 months following treatment
Exclusion Criteria:
* Abnormal liver function (ALT higher than 3 times the normal value);
* End-stage renal failure;
* Severe heart and pulmonary failure, or other important organs damage;
* Uncontrolled infections
* Pregnant or breast feeding women, male or female who intended to recent pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
British Isles Lupus Assessment Group score (BILAG)
Timeframe: up to 12 months
Trial details
NCT IDNCT01741857
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School